FDA.reportPublic FDA data

DemeSTEEL

Primary DI
30652927306706
Brand
DemeSTEEL
Company
DEMETECH CORPORATION
Model
SW113030F4P
Device description
Stainless Steel Surgical Non Absorbable Suture
Published
2019-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141007000DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREDemetech Corp.2014-09-25GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30652927306706PackageGS112In Commercial Distribution
10652927306702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065292730670630652927306706
1065292730670210652927306702

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA sterile, single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium, tantalum) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached needle intended to be disposed of after single use. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3058241048info@demetech.us

Regulatory Flags#

DUNS number
039436691
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
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10652927777540DemeFORCEFR390226B0P2026-04-20
10652927778240DemeFORCEFR312022026-04-20
10652927778257DemeFORCEFR312052026-04-20
10652927778264DemeFORCEFR312202026-04-20
10652927778271DemeFORCEFR35022026-04-20
10652927778288DemeFORCEFR35052026-04-20
10652927778295DemeFORCEFR35202026-04-20
10652927784890DemeDIOX BarbedPXB2982026B0U12026-04-20
10652927784951DemeDIOX BarbedPXB2983026B0U12026-04-20
10652927785132DemeDIOX BarbedPXB280148C0B2026-04-20
10652927785569DemeDIOX BarbedPXB883017B0U12026-04-20
10652927785606DemeFORCEFR350240B5P2026-04-20
10652927785613DemeFORCEFR4x350548B6P2026-04-20
10652927785644DemeDIOX BarbedPXB1182026B0U12026-04-20
10652927785651DemeDIOX BarbedPXB1183026B0U12026-04-20
10652927785699DemeDIOX BarbedPXB880037B0U12026-04-20
10652927785705DemeDIOX BarbedPXB882037B0U12026-04-20
10652927785835DemeDIOX BarbedPXB180140B0U12026-04-20
10652927785842DemeDIOX BarbedPXB180148B0U12026-04-20
10652927785965DemeDIOX BarbedPXB5383026B0U12026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10652927785309DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786085DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786092DemeSTEELDemetech CorporationGAQ2023-08-22
10652927777823DemeSTEELDemetech CorporationGAQ2022-12-21
10652927782926DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783176DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783183DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783190DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783206DemeSTEELDemetech CorporationGAQ2022-12-21
10652927722694DemeSTEELDemetech CorporationGAQ2020-10-13
10652927697220DemeSTEELDemetech CorporationGAQ2020-01-15
10652927669869DemeSTEELDemetech CorporationGAQ2019-12-24
10652927669876DemeSTEELDemetech CorporationGAQ2019-12-24
10652927684169DemeSTEELDemetech CorporationGAQ2019-12-24
10652927151050DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161042DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161172DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164265DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164371DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165026DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165033DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165576DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174226DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174233DemeSTEELDemetech CorporationGAQ2019-07-11
10652927176909DemeSTEELDemetech CorporationGAQ2019-07-11
10652927207382DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216797DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216841DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219736DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219743DemeSTEELDemetech CorporationGAQ2019-07-11