FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9380021010
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD938002101
Catalog number
SD938002101
Device description
5 7/8 inch Exodontia Cryer Elevator, #31, Tip Curved Down
Published
2022-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9380021010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal probe, reusableA hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382S28531030Surgical DirectS2853.103S2853.1032026-06-08
B382S28531040Surgical DirectS2853.104S2853.1042026-06-08
B382S2853252T0Surgical DirectS2853.252TS2853.252T2026-06-08
B382S285401100Surgical DirectS2854.110S2854.1102026-06-08
B382SD902172106T0Surgical DirectSD902172106TSD902172106T2026-06-08
B382SD9023191000Surgical DirectSD902319100SD9023191002026-06-08
B382SD9027351020Surgical DirectSD902735102SD9027351022026-06-08
B382SD9028531080Surgical DirectSD902853108SD9028531082026-06-08
B382SD9028531260Surgical DirectSD902853126SD9028531262026-06-08
B382SD9028531290Surgical DirectSD902853129SD9028531292026-06-08
B382SD9028531720Surgical DirectSD902853172SD9028531722026-06-08
B382SD9028541100Surgical DirectSD902854110SD9028541102026-06-08
B382SD9028541170Surgical DirectSD902854117SD9028541172026-06-08
B382SD902861100T0Surgical DirectSD902861100TSD902861100T2026-06-08
B382SD902869400Surgical DirectSD90286940SD902869402026-06-08
B382SD902870110Surgical DirectSD90287011SD902870112026-06-08
B382SD902991101T0Surgical DirectSD902991101TSD902991101T2026-06-08
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811885QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811892QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811908QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811915QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811922QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506839414QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506843862QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849239QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849253QuinelatoSchobell Industrial LtdaEIX2022-12-08
07899798200258QuinelatoSchobell Industrial LtdaEIX2022-12-08
10889950034726HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
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10889950034818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034832HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034849HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034856HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034863HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034870HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
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10889950034894HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12