FDA.reportPublic FDA data

Ballspike, Straight, L=300mm

Primary DI
09120115620007
Brand
Ballspike, Straight, L=300mm
Company
I.T.S. GmbH
Model
64010
Published
2022-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
09120115620007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120115620007091201156200079120115620007

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic ball spikeA hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
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
09120116973843Impactor1UI105A1UI105A2024-08-05
09120116973850PF Extension Endcap,+5mm, PPS1F0-15-05A-S1F0-15-05A-S2024-08-05
09120116973874PF Extension Endcap,+10mm, PPS1F0-15-10A-S1F0-15-10A-S2024-08-05
09120116973881PF Extension Endcap,+15mm, PPS1F0-15-15A-S1F0-15-15A-S2024-08-05
09120116973898PF Extension Endcap,+20mm, PPS1F0-15-20A-S1F0-15-20A-S2024-08-05
09120116973867PF Endcap, 0mm PPS1F0-10-30A-S1F0-10-30A-S2024-04-15
09120034300417Bending Iron66252-1466252-142018-11-08
09120034306419Small Plate Bending Iron KM 47-915KM 47-9152018-11-13
09120034306426Small Plate Bending Iron KM 47-916KM 47-9162018-11-13
09120047301883Bending HeaverKJ.206.14KJ.206.142018-11-14
09120047301890Bending HeaverKJ.207.14KJ.207.142018-11-14
09120069815429In-Situ Bending Iron66261662612018-11-08
09120069815436In-Situ Bending Iron66262662622018-11-08
09120069815443In-Situ Bending Iron66263662632018-11-08
09120034302626Fibula Plate PROlock21222-821222-82016-09-08
09120034302633Fibula Plate PROlock21222-621222-62016-09-08
09120034302640Fibula Plate PROlock21222-421222-42016-09-08
09120034302657Fibula Plate PROlock21221-821221-82016-09-08
09120034302664Fibula Plate PROlock21221-621221-62016-09-08
09120034302671Fibula Plate PROlock21221-421221-42016-09-08

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