FDA.report

GIJaw

Primary DI
10816734021641
Brand
GIJaw
Company
DIVERSATEK HEALTHCARE, INC.
Model
1190-03
Catalog number
1190-03
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

Related Records

Contact Domains

Product Codes

CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10816734021641PackageGS110In Commercial Distribution
00816734021644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081673402164110816734021641
00816734021644008167340216448167340216440816734021644

GMDN Terms

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

TypeValueUnit
Width2.3Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal

Sterilization Methods

Method

Contacts

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

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