FDA.reportPublic FDA data

Steri-Drape™ Ioban™ 2

Primary DI
50707387579581
Brand
Steri-Drape™ Ioban™ 2
Company
3M COMPANY
Model
6677P
Catalog number
6677P
Device description
3M™ Steri-Drape™ Cardiovascular Drape Pack with Ioban™ 2 Incise Film 6677P
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K801550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K8015500003M GERMICIDAL SURGICAL INCISE DRAPE3M Company1981-09-17KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387579581PrimaryGS10
00707387579586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738757958150707387579581
00707387579586007073875795867073875795860707387579586

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
4
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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007073878188903M™ Bair Hugger™55001550012026-05-15
007073878189063M™ Bair Hugger™55502555022026-05-15
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007073878189443M™ Bair Hugger™45035450352026-05-15
007073878189513M™ Bair Hugger™45535455352026-05-15
007073878189683M™ Bair Hugger™55078550782026-05-15
007073878189753M™ Bair Hugger™55578555782026-05-15
106058610760643M™ Filtek™6555A3-S6555A3-S2026-05-08
106058610773823M™ Filtek™4867A14867A12026-05-08
106058610773993M™ Filtek™4867A24867A22026-05-08
106058610774053M™ Filtek™4867A34867A32026-05-08
106058610774123M™ Filtek™4867B14867B12026-05-08

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