FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653178797
Brand
AESCULAP
Company
Aesculap AG
Model
OL670R
Catalog number
OL670R
Device description
KEYES Dermal Punch complete instrument, non-sterile, reusable
Published
2020-07-14
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
KAYPUNCH, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAYPunch, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653178797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653178797040386531787974038653178797

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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530693BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530709BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530716BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530723BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00848657077194AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAY2025-08-25
00194613081850MSI Precision Specialty InstrumentsMed Saver, Inc.KAY2025-08-01
00757770415847Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770426256Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770430840Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770404667Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770410842Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770418541Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770435531Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770457748Bausch + LombBausch & Lomb IncorporatedKAY2024-11-19
04049197392938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197392945RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197392952RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449083RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
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04049197449106RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
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04049197450096RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450102RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450188RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450195RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450201RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450232RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450249RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450256RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197524728RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16