FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105221784
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
ZCIN-01SM65A
Device description
#65A Micro Blades, Box of 25
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105221784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105221784008401052217848401052217840840105221784

GMDN Terms#

Term, Definition table
TermDefinition
Manual scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags#

DUNS number
005449822
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
00840105223009ZOLL DENTALSYR-4962-22023-07-11
00840105223818ZOLL DENTALZ-49342025-09-16
00840105223825ZOLL DENTALZ-49362025-09-16
00840105223832ZOLL DENTALZ-49372025-09-16
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105215226ZOLL-DENTALZ-10TKP2021-03-10
00840105215714ZOLL-DENTALZ-11TKP2021-03-10
00840105215967ZOLL-DENTALZ-12TKP2021-03-10
00840105216131ZOLL-DENTALZ-19-274-13-P2021-03-10
00840105216148ZOLL-DENTALZ-19-274-13-T2021-03-10
00840105216155ZOLL-DENTALZ-19-274-162021-03-10
00840105218388ZOLL-DENTALZ-44382021-03-10
00840105220268ZOLL-DENTALZ-71451-002021-03-10
00840105220275ZOLL-DENTALZ-71451-012021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
08902895180190KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180206KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180213KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180220KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180237KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180244KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180268KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180275KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180282KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180299KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180305KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180336KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182101KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182125KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182156KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182200KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182217KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06