FDA.reportPublic FDA data

CASE MEDICAL

Primary DI
00653159012686
Brand
CASE MEDICAL
Company
Case Medical Inc.
Model
SCS01SH-5
Catalog number
SCS01SH-5
Device description
TAMPER EVIDENT SHARPEN (500 PK)
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653159012686PrimaryGS10
10653159012683Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159012686006531590126866531590126860653159012686
1065315901268310653159012683

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, single-useA label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed as a locking tag. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053057972
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653159013232CASE MEDICAL973653197365312026-03-20
00653159013256CASE MEDICAL973653097365302026-03-20
00653159014062CASE MEDICAL973652997365292026-03-20
00653159014086CASE MEDICAL973652497365242026-03-20
00653159014123CASE MEDICAL973652397365232026-03-20
00653159014727CASE MEDICAL973652697365262026-03-20
00653159014734CASE MEDICAL973652797365272026-03-20
00653159014741CASE MEDICAL973652597365252026-03-20
00653159014987CASE MEDICAL973653497365342026-03-20
00653159015007CASE MEDICAL973652897365282026-03-20
00653159015182CASE MEDICAL973663297366322026-03-20
00653159015229CASE MEDICAL973663397366332026-03-20
00653159013751CASE MEDICALKSZ-39301TSKSZ-39301TS2026-02-03
00653159012709CASE MEDICALBR10-092BR10-0922026-01-29
00653159016967CASE MEDICALKSZ-39312FESS-R2KSZ-39312FESS-R22026-01-29
00653159016974CASE MEDICALKSZ-39312FESS-R3KSZ-39312FESS-R32026-01-29
00653159016981CASE MEDICALKSZ-39312FESS-R4KSZ-39312FESS-R42026-01-29
00653159016998CASE MEDICALKSZ-39301LTA-RKSZ-39301LTA-R2026-01-29
00653159017001CASE MEDICALKSZ-39312C-R1KSZ-39312C-R12026-01-29
00653159017018CASE MEDICALKSZ-39312C-R2KSZ-39312C-R22026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178506MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178513MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178568MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178650MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178667MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178698MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177967MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15