FDA.reportPublic FDA data

BEAR

Primary DI
G043209030
Brand
BEAR
Company
Bear-Ent, LLC
Model
2.09.03
Catalog number
2.09.03
Device description
Kelly-Rankin Hemostatic Forceps, 16cm, Straight
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043209030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123551586
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G04320061G0GEIZ2.00.61.G2.00.61.G2026-05-26
G04320062G0GEIZ2.00.62.G2.00.62.G2026-05-26
G04320065G0GEIZ2.00.65.G2.00.65.G2026-05-26
G04320067G0GEIZ2.00.67.G2.00.67.G2026-05-26
G04320068G0GEIZ2.00.68.G2.00.68.G2026-05-26
G043200600BEAR2.00.602.00.602022-08-03
G043200610BEAR2.00.612.00.612022-08-03
G043200620BEAR2.00.622.00.622022-08-03
G043200630BEAR2.00.632.00.632022-08-03
G043200640BEAR2.00.642.00.642022-08-03
G043200650BEAR2.00.652.00.652022-08-03
G043200660BEAR2.00.662.00.662022-08-03
G043200670BEAR2.00.672.00.672022-08-03
G043200680BEAR2.00.682.00.682022-08-03
G043MLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2022-05-19
G043MLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2022-05-19
G043MLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2022-05-19
G043MLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2022-05-19
G043MLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2022-05-19
G043MLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2022-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811010155INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811151162INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
G586D75480250NovosurgicalNOVO SURGICAL, INC.GEN2024-12-30
KTS1017012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1018012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1222112K.T.SurgicoK.T.SURGICOGEN2024-02-20
GYNX32071GynexGYNEX CORPORATIONGEN2023-12-26
07898506812424QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812479QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812516QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812639QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812646QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812691QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812769QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812806QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812813QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813803QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813810QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506850198QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506852772QuinelatoSchobell Industrial LtdaGEN2023-01-10