FDA.reportPublic FDA data

CROC Multiple Sample Single-Use Biopsy Forceps

Primary DI
10666416140227
Brand
CROC Multiple Sample Single-Use Biopsy Forceps
Company
Primed Instruments Inc
Model
MC924A
Catalog number
MC924A
Device description
Single-Use Multiple Sample Biopsy Forceps with serrated jaws and ezSlide® sheath. HIBC/UPN: M453MC924A1
Published
2018-11-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10666416140227PrimaryGS10
00666416140220Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066641614022710666416140227
00666416140220006664161402206664161402200666416140220

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Instruments should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Each dispenser box contains 5 devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-565-0565info@primedinstruments.com

Regulatory Flags#

DUNS number
254491293
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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