FDA.reportPublic FDA data

Scalpel Handle

Primary DI
09120116973782
Brand
Scalpel Handle
Company
I.T.S. GmbH
Model
1UI015A
Catalog number
1UI015A
Device description
Scalpel Handle
Published
2024-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GDXSCALPEL, ONE-PIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120116973782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120116973782091201169737829120116973782

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
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
00810111227346Scalpel Treace Medical Concepts, Inc.GDX2026-05-19
00850069257002LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257019LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257026LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257040LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257057LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257064LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257071LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257088LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257095LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257101LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257118LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257033LumohsNANO SURGICAL, INCGDX2026-02-20
16945630141826STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INCGDX2025-11-21
16945630137584index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137591index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137607index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137614index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139069index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139076index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
10198459343490MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GDX2025-05-22
16945630114080BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
10197344025190MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025206MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025213MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
08902895129212KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129229KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129236KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129243KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09