FDA.reportPublic FDA data

PATTERSON

Primary DI
D6620708992032
Brand
PATTERSON
Company
PATTERSON DENTAL SUPPLY, INC.
Model
089-9203
Device description
PATTERSON 3-0 BBS SPOOL 100 YD
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930826000SUTURE NONABSORBABLE - SILKSurgical Specialties, Inc.1994-01-07GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6620708992032PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture, non-sterileA non-sterile, single-strand (monofilament), natural, non-bioabsorbable thread made from raw silk spun by silkworms intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it must be sterilized before use and may include an attached needle intended to be disposed of after single use. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it is typically digested by proteolysis after an extended period of time. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
171843584
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D66207043102302Patterson®043-1023704310232024-11-11
D6620704340920Patterson®043-4092704340922024-11-11
D6620708296480PATTERSON0708296482018-09-18
D6620708394560PATTERSON0708394562018-09-18
D6620708996740PATTERSON 089-96742015-09-25
D6620708325012PATTERSON0708325012016-09-23
D6620708325192PATTERSON0708325192016-09-23
D6620704115790Patterson®70411579704115792016-09-23
D6620708903840Patterson®70890384708903842016-09-23
D66207111063405Patterson®71110634711106342024-05-08
D6620711869150Patterson®71186915711869152024-05-08
D6620711869310Patterson®71186931711869312024-05-08
D6620714708480Patterson®25-PAT714708482025-02-06
D6620714708550Patterson®15-PAT714708552025-02-06
D6620714708630Patterson®65-PAT714708632025-02-06
D6620714708710Patterson®204-PAT714708712025-02-06
D6620714708890Patterson®57-PAT714708892025-02-06
D6620714969590Patterson®22-PAT714969592025-02-06
D6620708506692Patterson®70850669708506692016-09-23
D6620708506932Patterson®70850693708506932016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00381780363883Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGAP2017-01-05
04038653826230SilkamB BRAUN SURGICAL SAGAP2015-11-12
04038653826469SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653826513SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653741502SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741526SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741601SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741700SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741786SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741816SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741830SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741854SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741892SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741915SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742196SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742257SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742271SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742776SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742936SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742950SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742974SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742998SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741243SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741281SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741403SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741441SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741625SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743131SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743438SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743414SilkamB BRAUN SURGICAL SAGAP2015-08-20