FDA.reportPublic FDA data

Biopsy forceps

Primary DI
04059082019727
Brand
Biopsy forceps
Company
SOPRO-COMEG GmbH
Model
393 520 106
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945266000OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESOptus, Inc.1995-02-23GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059082019727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059082019727040590820197274059082019727

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
507185952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059082002743Arthroscope161 191 040BC0012016-09-12
04059082002750Arthroscope161 240 980BC0012016-09-12
04059082002767Arthroscope161 240 982BC0012016-09-12
04059082002774Cystoscope161 271 140BC0012016-12-22
04059082002781Arthroscope161 271 190BC0012016-09-12
04059082002798Arthroscope161 271 192BC0012016-09-12
04059082002811Sinuscope161 271 760BC0012016-09-12
04059082002835Sinuscope161 271 762BC0012016-09-12
04059082002859Sinuscope161 271 765BC0012016-09-12
04059082002866Arthroscope161 271 770BC0012016-09-12
04059082002880Arthroscope161 271 772BC0012016-09-12
04059082002903Arthroscope161 271 775BC0012016-09-12
04059082002927Sinuscope161 271 780BC0012016-09-12
04059082002941Sinuscope161 271 782BC0012016-09-12
04059082002965Sinuscope161 271 785BC0012016-09-12
04059082003115Sinuscope161 401 800BC0012016-09-12
04059082003139Sinuscope161 401 802BC0012016-09-12
04059082003153Sinuscope161 401 803BC0012016-09-12
04059082003160Sinuscope161 401 805BC0012016-09-12
04059082003184Sinuscope161 401 810BC0012016-09-12

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Primary DI, Brand, Company table
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B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
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00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
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00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
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