FDA.report

DRAPES sterile

Primary DI
04049539101167
Brand
DRAPES sterile
Company
Carl Zeiss Meditec AG
Model
326088-0000-000
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KKXDrape, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049539102096PackageGS120In Commercial Distribution
04049539102300PackageGS110In Commercial Distribution
04049539101167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049539102096040495391020964049539102096
04049539102300040495391023004049539102300
04049539101167040495391011674049539101167

GMDN Terms

TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Device Sizes

TypeValueUnit
Height14Inch
Height36Centimeter
Width6Inch
Width15Centimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
342228620
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539064080INTRABEAM7002025-04-01
04049539066503INTRABEAM SMART Stand66502025-04-01
04049539066435TIVATO® 70066432025-01-22
04049539106018SMARTDRAPE306030-0000-0002025-01-22
04049539106070INTRABEAM SMARTDRAPE326091-0000-0002025-01-22
04049539106094SMARTDRAPE306029-0000-0002025-01-22
04049539106889EyeMag Smart TTL000000-2560-2932025-01-22
04049539106896EyeMag Classic000000-2560-6882025-01-22
04049471095074MEL 90 1900-1092024-12-13
04049471095111VISUMAXVISUMAX 800 or 095112024-12-13
04049539106704Single-use lenses for RESIGHT, MACULA LENS302721-9107-0002024-11-07

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