FDA.reportPublic FDA data

NA

Primary DI
10886982278685
Brand
NA
Company
Synthes GmbH
Model
SD398.752
Catalog number
SD398752
Device description
SHAFT ATTACHMENT COLLINEAR REDUCTION CLAMP ADD
Published
2018-06-07
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
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982278685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698227868510886982278685

GMDN Terms#

Term, Definition table
TermDefinition
Assistive laundry clotheslineA technical laundry aid designed to be used by a person with a disability upon which they can hang wet or damp clothing for this to dry. It is designed as a flexible line that can be horizontally tensioned upon which the clothing is hung. It typically consists of several parallel lines held within a holder that is affixed to a wall; the loose end is stretched to a second anchorage point on an adjacent wall when in use. It is typically folded together for convenient storage when not in use.

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
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD90120123T0Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9012101000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901229040Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9012941000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901294100T0Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9012981000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901345140Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901365200Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9015171000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9015171010Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD90190030Surgical DirectSurgical Direct, Inc.HTD2026-10-22
00190776435776MillenniumAvalign Technologies, Inc.HTD2026-10-21
00190776435783MillenniumAvalign Technologies, Inc.HTD2026-10-21
B382SD915758300Surgical DirectSurgical Direct, Inc.HTD2026-10-20
00190776435356MillenniumAvalign Technologies, Inc.HTD2026-10-19
00190776435158MillenniumAvalign Technologies, Inc.HTD2026-10-16
00192896123878Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123885Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123892Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123908Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123915Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00190776434717MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434748MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434755MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434243MillenniumAvalign Technologies, Inc.HTD2026-10-09
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD918660100Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07