FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340001960
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
07-KC02
Device description
Knob Cover
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340001960PackageGS125In Commercial Distribution
00848340001963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000196010848340001960
00848340001963008483400019638483400019630848340001963

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, single-use, sterileA sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848340018213Urological Drainage BagKTEK84112026-05-07
00848340018220Urological Drainage BagKYRA84102026-04-15
00848340018206Urological Drainage BagKTEK84102026-04-13
00848340010712C-FlexA-707022026-03-12
10848340010719C-FlexA-707022026-03-12
00848340014857Asonic GelASG-0012023-06-13
00848340002212Transducer Cover05-TC9962024-02-05
00848340002229Custom Cover08-CC1242024-02-06
00848340002236Custom Cover08-CC1342024-02-07
00848340002243Custom Cover08-CC1372024-02-07
00848340002250Custom Cover08-CC1392024-02-08
00848340002267Custom Cover08-CC1402024-02-08
00848340002281Camera Cover08-CC1492024-02-12
00848340002298Cassette Drape08-CC1502024-02-15
00848340002311Snap Kover08-CC1622024-02-15
00848340002328Custom Pack08-CC1632024-02-15
00848340002335Custom Pack08-CC1702024-02-20
00848340002342Positioning Arm Drape08-CU15612024-02-21
00848340002359Doppler Flow Wire CoverDFC1002024-03-13
00848340002366Doppler Flow Wire CoverDFC1012024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04064434000209Heidelberg OPERAMunich Surgical Imaging GmbHHRM2026-05-14
00380650008374UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008381UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008398UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008404UNITYAlcon Laboratories, Inc.HRM2026-04-09
04049584037909Cable SDI BIOM 6 for Alcon LuxOR RevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLumaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037695Focusing Module BIOM 6, 175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037701Focusing Module BIOM 6, 200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037718Precision Mount for B&LOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037725Precision Mount for LeicaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037732Precision Mount for AlconOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037749Precision Mount for ZeissOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037756Precision Mount for Haag StreitOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037152BIOM 6OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-14
00454745102558INAMIINAMI & CO., LTD.HRM2025-11-12
04547451081777INAMIINAMI & CO., LTD.HRM2025-11-12
07630802403711PROVEO 8xLeica Microsystems (Schweiz) AGHRM2025-10-03
04064434000193SeeLuma Digital Binoculars ModuleMunich Surgical Imaging GmbHHRM2025-08-05
06972039971061MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971078MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971221MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
01836230004391Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
01836230004407Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004390Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004406Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16