FDA.report

AESCULAP

Primary DI
04038653169771
Brand
AESCULAP
Company
Aesculap AG
Model
FO937R
Catalog number
FO937R
Device description
Tendon Stripper, 12" (300 mm), diam. 5 mm, closed
Published
2020-04-22
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
HRTSTRIPPER, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653169771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653169771040386531697714038653169771

GMDN Terms

TermDefinition
Vein stripper, reusableA hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). 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
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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462573N/ADoppkon GmbH & Co. KGHRT2025-12-01
04262494462559N/ADoppkon GmbH & Co. KGHRT2025-11-28
B7685410380Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
B7685410410Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
00757770409112Bausch + LombBausch & Lomb IncorporatedHRT2025-08-15
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844101117INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844101155INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
04047844126998INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-06-04
00190776398071MillenniumAvalign Technologies, Inc.HRT2025-05-19
00190776398088MillenniumAvalign Technologies, Inc.HRT2025-05-19
00190776398095MillenniumAvalign Technologies, Inc.HRT2025-05-19
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-05-09
B7685411140Buxton BioMedicalBuxton Biomedical IncHRT2025-05-07
04047844058442INSTRUMENTSIGNUS Medizintechnik GmbHHRT2025-05-05
00840319758007Hayden MedicalHayden Medical, Inc.HRT2025-04-30
00810077631447Stripper Scribe ToolOPTICAL INTEGRITY INCHRT2025-04-11
04055207021194NARichard Wolf GmbHHRT2025-03-20
00840019969055Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14
00840019969062Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14
00840019969079Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14
00840019969086Dakota ALIF SystemPRECISION SPINE, INC.HRT2025-03-14