DEKNATEL BW-102

GUDID 34026704635659

Bone Wax Contents: One (1) Bars 2.5 Grams

TELEFLEX INCORPORATED

Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural Bone wax, natural

• Primary Device ID: 34026704635659
• NIH Device Record Key: 06df0322-1f45-4240-a77f-38f7ed2468f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKNATEL
• Version Model Number: IPN029172
• Catalog Number: BW-102
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026704590476 [Previous]
GS1	14026704635655 [Primary]
GS1	34026704635659 [Package]; Contains: 14026704635655; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050292

FDA Product Code

• MTJ: Wax, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

[34026704635659]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-16
• Device Publish Date: 2019-05-14

On-Brand Devices [DEKNATEL]

• 14026704590275: TEV WH BR 6-0 XT-6 5 2N 24" X 4 PF
• 14026704590268: TEV GN BR 6-0 XT-6.5 2N 24" X4 PF
• 34026704596370: DR MESSIER CABG KIT
• 44026704596360: DR MCINTYRE CABG KIT
• 14026704592750: STL MF 5 K-60 2N 30"
• 14026704592699: RC SLK BK BR 3-0 30"X12
• 14026704592682: RC SLK BK BR 0 18"X12
• 14026704592651: RC SLK BK BR 2 60"X2
• 14026704592613: SLK BK BR 4-0 T-3 2N 30
• 14026704592514: SLK BK BR 3-0 C-2 1N 30
• 14026704555199: V-PAK (B7-7040)X5 (B7-7040W)X5
• 14026704555069: V-PAK (F69-717) X5 (F69-717W)X5
• 44026704554933: V-PAK ASST'D SUTURES
• 14026704428622: SLK BK BR 3-0 T-4 1N 30
• 14026704428004: RC TEV GN BR 2 30"X3
• 14026704427816: STL MF 1 C-2 1N 18"X5
• 14026704427434: STL MF 6 6(B-60) 2(K-60) 18"X8
• 14026704427243: STL MF 5 1(K-60) 6(B-60)18"X7
• 14026704427229: STL MF 7 4(K-60) 4(B-60)18"X8
• 14026704427113: STL MF 2 KC-6 1N 18"X4
• 14026704427069: RC TEV GN BR 2 24" X6
• 14026704425843: SLK BK BR 1 KC-6 1N 30"
• 14026704425805: V-PAK (X79-774W)X5 (79-774)X5
• 14026704425591: V-PAK ASST'D SUTURES
• 14026704425164: V-PAK (B7-7037)X15
• 14026704424792: V-PAK (XH79-799G)X4 (XH79-799W)X4
• 14026704424136: SLK BK BR 3-0 C-2 2N 30
• 14026704424129: SLK BK BR 0 C-2 1N 30"
• 14026704424020: RC TIE PAK BK BR SLK X3
• 14026704421753: TEV GN BR 4-0 KT-3 2N 30"
• 14026704421654: TEV GN BR 2 K-61 1N 30
• 14026704421647: TEV GN BR 5 K-61 1N 30"
• 14026704421593: TEV GN BR 5 K-60 1N 30"
• 14026704421340: RC TEV GN BR 2 18"X3
• 14026704421302: TEV GN BR 0 KC-2 1N 30"
• 14026704421210: RC TEV GN BR 2-0 24"X12
• 14026704420756: TEV GN BR 5 CE-75 1N 36
• 14026704420558: TEV GN BR 2-0 C-2 2N 30
• 14026704420176: POL GN BR 3-0 KS-1 1N 30"
• 44026704590078: RC TEV GN BR 2 24"
• 44026704427466: CTY WH TP 5MM KC-25 1N 40"
• 44026704427251: CTY WH TP 1MM K-61 1N 20"
• 44026704426742: PLED SOFT 1 1/2"X1 1/2
• 44026704426261: CTY WH TP 3MM KC-25 2N 30"
• 44026704426155: CTY WH TP 5MM C-25 1N 12"
• 44026704423888: TEV GN BR 4-0 T-10 2N 30" PFS
• 44026704423864: PLED SOFT LG 3/8"X3/16"X1/16" X100NS
• 24026704413793: TEV G/W 2-0 HRT26 2N 4X75CM PFM
• 24026704413786: TEV G/W 2-0 HRT17 2N 4X75CM PFM
• 24026704647952: TEVDEK GREEN BRAIDED 2-0 C-2 2N 30 PFL