FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KAYPUNCH, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KAYPunch, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653178797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653178797040386531787974038653178797

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

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
04049197449090RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449106RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449113RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
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