FDA.reportPublic FDA data

TSPACE

Primary DI
04038653453375
Brand
TSPACE
Company
Aesculap AG
Model
FJ685R
Catalog number
FJ685R
Device description
TSPACE BONE RASP 45°LT.ANG 10/350MM
Published
2020-06-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653453375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653453375040386534533754038653453375

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
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
B35675400020American MedicalsAmerican MedicalsGAC2026-05-20
05055445940881SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940898SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940904SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940911SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940928SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973001SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973018SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973025SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973032SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
00190776421014MillenniumAvalign Technologies, Inc.GAC2026-04-30
B356ED469970American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470040American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470050American MedicalsAmerican MedicalsGAC2026-04-07
B356FF114000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115020American MedicalsAmerican MedicalsGAC2025-05-27
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277385863MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29