FDA.report

Tevdek II

Primary DI
00889989079494
Brand
Tevdek II
Company
ORMCO CORPORATION
Model
975-0050
Device description
Green Braided PTFE Impregnated Polyester Fiber - Nonabsorbable Surgical Suture
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications

CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889989079494PrimaryGS10
10889989079491Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989079494008899890794948899890794940889989079494
1088998907949110889989079491

GMDN Terms

TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+18005377123EndoRotaryCustCare@kerrdental.com

Regulatory Flags

DUNS number
154614119
Device count
12
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
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00889989074154Pulp Canal Sealer248732016-09-08
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00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989074239Tubli-Seal EWT Xpress336412016-09-08
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00889989088892Ormco™ EtchFree Bonding740-05102025-05-09
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10889989088912Ormco™ EtchFree Bonding740-05252025-05-09
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10889989012269Straight-Wire Synthesis338-03112024-03-07
10889989012276Straight-Wire Synthesis338-04102024-03-07

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Primary DIBrandCompanyProduct codePublished
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