FDA.reportPublic FDA data

XRL

Primary DI
10705034723402
Brand
XRL
Company
Synthes GmbH
Model
03.807.374
Catalog number
03807374
Device description
XRL MEDIUM GRAFT PACKING PREPARATION TAMP
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXGTAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819406377Direct MarkingGS10
10705034723402PrimaryGS10
H981038073740SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819406377076118194063777611819406377
1070503472340210705034723402

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft inserter, reusableA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8035506760ORTHOMEDORTHO-MED, INC.HXG2026-06-22
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
08800322752098AnyPlus®GS Medical Co., Ltd.HXG2026-01-28
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
00841732142206GENERIC Surgical InstrumentsCTL Medical CorporationHXG2025-03-31
00841732166950GENERIC Surgical InstrumentsCTL Medical CorporationHXG2024-11-01
08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058279SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058286SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25