FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653177585
Brand
AESCULAP
Company
Aesculap AG
Model
OK737R
Catalog number
OK737R
Device description
"KOFLER Bone Punch, 90 °, rotates 360°, 5 3/4"", (145 mm), width: 3 mm, non-sterile, reusable"
Published
2020-06-17
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
KAWPUNCH, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAWPunch, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653177585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653177585040386531775854038653177585

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770508570Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508587Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508594Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508600Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508631Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508648Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508662Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00840183530730BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00840183530747BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00194613011499MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029326MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029364MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047214MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047221MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613061739MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081393MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081447MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081508MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081560MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613085568MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613088842MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613091507MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613094720MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613095062MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102104MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102111MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613106171MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613123765MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00757770508563Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508624Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31