ZOLL-DENTAL

GUDID 00840105200307

Chandler #8

Zoll-Dental

Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome
Primary Device ID00840105200307
NIH Device Record Key31c3f98d-1bce-4190-9fd0-b8069034bc1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameZOLL-DENTAL
Version Model NumberBC-C8
Company DUNS005449822
Company NameZoll-Dental
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM
Phone+1(847)647-1819
EmailJEFF@ZOLLDENTAL.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100840105200307 [Primary]

FDA Product Code

EMLCHISEL, BONE, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

[00840105200307]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-23
Device Publish Date2019-09-13

On-Brand Devices [ZOLL-DENTAL]

00840105200475Bone Chisel (Custom Finish)
00840105200468McFarland #18
00840105200451KN-7
00840105200444KN-5
00840105200437Gardner #9
00840105200420Gardner #6
00840105200413Gardner #5R
00840105200406Gardner #5
00840105200390Gardner #2
00840105200383Gardner #1
00840105200376Freer SCB 6.0mm
00840105200369Freer SCB 4.0mm
00840105200352Freer SCB 2.0mm
00840105200345Freer DCB 6.0mm
00840105200338Freer DCB 4.0mm
00840105200321Freer DCB 2.0mm
00840105200314Chandler #9
00840105200307Chandler #8
00840105200291Chandler #7
00840105200284Chandler #6
00840105200277Chandler #5
00840105200260Chandler #4
00840105200253Chandler #3
00840105200246Chandler #2
00840105200239Chandler #1
00840105200222Chandler #15
00840105200215Chandler #13
00840105200208Wakefield #2W
00840105200192Wakefield #1W
00840105205463Perio Knife (Custom Finish)
00840105205456Orban #1/2 Modified-Short
00840105205449Orban #1/2 Modified-Long
00840105205432Orban #1/2
00840105205425Merrifeld #3/4
00840105205418Kirkland #15K/16K
00840105205401Goldman-Fox GF-9
00840105205395Goldman-Fox GF-8
00840105205388Goldman-Fox GF-7
00840105205371Goldman-Fox GF-11
00840105205364Buck #5/6
00840105205357Buck #3/4
00840105205340AIP-1 Tunneling Instrument
00840105205333AIK-2 Knife
00840105205326AIK-1 Knife
00840105205319Explorer #23
00840105205302Explorer (Custom Finish)
00840105205296Explorer TU17
00840105205289Explorer #6 Rigid
00840105205272Explorer #6
00840105205265Explorer #6A
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