FDA.reportPublic FDA data

A-SPACE

Primary DI
04046963081652
Brand
A-SPACE
Company
Aesculap AG
Model
SJ047R
Catalog number
SJ047R
Device description
A-SPACE PEEK TRIAL IMPL.SIZE S 6° 17MM
Published
2021-04-23
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963081652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963081652040469630816524046963081652

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.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
04046964694165AESCULAPPL741SUPL741SU2016-09-23
04046964809392AESCULAPPL739SUPL739SU2016-10-10
04046964810411AESCULAPPL743SUPL743SU2016-10-10
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795150073APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWT2026-10-12
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
00810129551846OvertureTiOverture Resurfacing IncHWT2025-07-23
00810112599534PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599541PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599558PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599565PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599572PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599589PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599596PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599602PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599619PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599626PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599633PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599640PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599657PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599664PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599671PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599688PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599695PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599701PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599718PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12