Sterimed

Primary DI
20850341007800
Brand
Sterimed
Company
STERIMED LLC
Model
ZG1001
Device description
Microscope Drape (Laser Arm Attached) 40.5" X 120"
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853044000STERICOVERSterimed, Inc.1985-11-01IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850341007803PackageGS15In Commercial Distribution
20850341007800PackageGS18In Commercial Distribution
00850341007806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085034100780310850341007803
2085034100780020850341007800
00850341007806008503410078068503410078060850341007806

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-387-0771xx@xx.xx

Regulatory Flags#

DUNS number
080284658
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850341007349SterimedMB00622016-09-19
00850341007356SterimedMB00962016-09-19
00850341007363SterimedMG01052016-09-19
00850341007370SterimedMR00822016-09-19
00850341007387SterimedMR01202016-09-19
00850341007394SterimedPB10032016-09-19
00850341007479SterimedWG01052016-09-19
00850341007486SterimedWR01202016-09-19
00850341007493SterimedWR01502016-09-19
00850341007509SterimedWR10102016-09-19
00850341007516SterimedZB10052016-09-19
00850341007523SterimedZG00822016-09-19
00850341007752SterimedMR01502016-09-19
00850341007776SterimedTR0105B2016-09-19
00850341007790SterimedZB00962016-09-19
00850341007806SterimedZG10012016-09-19
00850341007813SterimedZG10062016-09-19
00850341007905SterimedZG10072016-09-19
00860001790207Sterimed0888NT0888NT2019-05-16
00860001790214Sterimed3520SB2020-04-27

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