FDA.reportPublic FDA data

Surgitube®

Primary DI
00809958001103
Brand
Surgitube®
Company
Derma Sciences Canada Inc
Model
220
Catalog number
GL-220
Device description
1 in X 50 yds Tubular Gauze, White
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809958001103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958001103008099580011038099580011030809958001103

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast or splint; or to cover a stump when a prosthesis is worn. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
200564891
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00809958093108Ducare®9409SDUP9409S2019-03-06
00809958013502Dupress®11903DUP119032018-11-13
00809958013601Dupress®11904DUP119042018-11-13
00809958013809Dupress®11907DUP119072018-10-23
00809958013908Dupress®11908DUP119082018-10-23
00809958080115DuCare®82208DUP822082018-10-23
00809958080214DuCare®82212DUP822122018-10-23
00809958080412DuCare®82312DUP823122018-10-23
00809958080511DuCare®82408DUP824082018-10-23
00809958080610DuCare®82412DUP824122018-10-23
00809958080719DuCare®82812DUP828122018-10-23
00809958080818DuCare®82815DUP828152018-10-23
00809958082010DuCare®82910DUP829102018-10-23
00809958084113DuCare®82410DUP824102018-11-20
00809958087411PrimaPad®83338DUP833382018-10-23
00809958087510PrimaPad®83334DUP833342018-10-23
00809958087619PrimaPad®83323DUP833232018-10-23
00809958090510DuCare®90208DUP902082018-11-13
00809958090619DuCare®90212DUP902122018-11-13
00809958090718DuCare®90308DUP903082018-11-13

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07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350929640Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350094850Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
07333350874889Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
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00850087488273CeeportCEEPORT INC.FQM2026-06-08
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