FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD934496030
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD93449603
Catalog number
SD93449603
Device description
5 Inch Culler Iris Spatula, 1mm Tip
Published
2023-02-22
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
B382SD934496030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. 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
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

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
10889950034733HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034757HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034764HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034771HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034788HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034795HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034801HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
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
10889950034887HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034894HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12