FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653026920
Brand
AESCULAP
Company
Aesculap AG
Model
BH655R
Catalog number
BH655R
Device description
"KOCHER-OCHSNER Hemostatic Forceps, curved, 11"", (280 mm), toothed (1x2), non-sterile, reusable"
Published
2020-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRQHEMOSTAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653026920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653026920040386530269204038653026920

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
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
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810055250707Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250714Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259687Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259694Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259700Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259717Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259724Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259731Surgical DesignSurgical Design, Inc.HRQ2026-05-27
10193489456325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HRQ2022-08-04
ESAM3800121STOMA®Storz am Mark GmbHHRQ2020-08-27
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ESAM3805121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3826141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3827141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3839141STOMA®Storz am Mark GmbHHRQ2020-08-27
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