FDA.reportPublic FDA data

GIJaw

Primary DI
10816734021627
Brand
GIJaw
Company
DIVERSATEK HEALTHCARE, INC.
Model
1190-01
Catalog number
1190-01
Device description
GIJaw Single-Use Biopsy Forceps with Needle
Published
2018-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816734021627PackageGS110In Commercial Distribution
00816734021620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081673402162710816734021627
00816734021620008167340216208167340216200816734021620

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816734023515BullDog®1203-401203-402025-12-05
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16
00816734023457Diversatek HealthcareHRIMSD-KITHRIMSD-KIT2025-05-16
00816734023464Diversatek HealthcareHRAM-KITHRAM-KIT2025-05-16
00816734023471Diversatek HealthcareEMG-KITEMG-KIT2025-05-16
00816734023488Diversatek HealthcareCOMP-KITCOMP-KIT2025-05-16
00816734023426Zvu®ZVU-3 Revision 3.4.0ZVU-32025-03-26
10816734023416BullDog®1203-931203-932024-11-22
M78312011101Diversatek Healthcare1201-1101201-1102024-10-31
10816734023362EZ-Ject1186-011186-012024-07-18
10816734023379EZ-Ject1186-021186-022024-07-18
10816734023386EZ-Ject1186-031186-032024-07-18
10816734023393EZ-Ject1186-041186-042024-07-18
M78312011081Diversatek Healthcare1201-1081201-1082024-06-07
M78312011061Diversatek Healthcare1201-1061201-1062024-01-31
10816734023355BullDog®1203-611203-612023-08-25
00816734023181SafeGuide® Single1215-151215-152023-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941513200089Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
00190776418021MillenniumAvalign Technologies, Inc.FCL2026-03-23
06970671381569AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2026-03-23
G3731433010Zinnanti SurgicalZinnanti Surgical Design Group IncFCL2026-03-04
00190776415617MillenniumAvalign Technologies, Inc.FCL2026-01-28
18051887049841THD BIOPSYTHD SPAFCL2026-01-07
18051887049865THD BIOPSYTHD SPAFCL2026-01-07
18051887049889THD BIOPSYTHD SPAFCL2026-01-07
06970671381026AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381040AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381187AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381200AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381248AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381323AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381347AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381491AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381545AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970800684059AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381361AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-08-08
06970671381385AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-08-08
00194613029449MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029456MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029463MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029470MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613034511MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01