FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD934444110
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD93444411
Catalog number
SD93444411
Device description
5 1/2" Kirby Intra-Capsular Lens Loop, Slender Loop
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNESnare, Enucleating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNESnare, EnucleatingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD934444110PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD402590Surgical DirectSD40259SD402592026-11-03
B382SD429490Surgical DirectSD42949SD429492026-11-03
B382SD62031510Surgical DirectSD62-031-51SD62-031-512026-11-04
B382SD89259100Surgical DirectSD8925-910SD8925-9102026-11-03
B382SD89519020Surgical DirectSD8951-902SD8951-9022026-11-03
B382SD902171200Surgical DirectSD90217120SD902171202026-11-04
B382SD9146531600Surgical DirectSD914653160SD9146531602026-11-04
B382SD9146531620Surgical DirectSD914653162SD9146531622026-11-04
B382SD9146531630Surgical DirectSD914653163SD9146531632026-11-04
B382SD9146531640Surgical DirectSD914653164SD9146531642026-11-04
B382SD9152181060Surgical DirectSD915218106SD9152181062026-11-03
B382SD9152181070Surgical DirectSD915218107SD9152181072026-11-03
B382SD9180201110Surgical DirectSD918020111SD9180201112026-11-04
B382SD921171120Surgical DirectSD92117112SD921171122026-11-03
B382SD921171190Surgical DirectSD92117119SD921171192026-11-03
B382SD922864110Surgical DirectSD92286411SD922864112026-11-03
B382SD922864120Surgical DirectSD92286412SD922864122026-11-03
B382SD922864130Surgical DirectSD92286413SD922864132026-11-03
B382SD9233161140Surgical DirectSD923316114SD9233161142026-11-03
B382SD9340311010Surgical DirectSD934031101SD9340311012026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770417810Bausch + LombBausch & Lomb IncorporatedHNE2024-11-19
00757770403042Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770403684Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770403950Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770404568Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770405701Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770407149Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770408511Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410019Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410286Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410965Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411092Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411252Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411696Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411993Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413065Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413126Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413706Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770415205Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417384Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417759Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420216Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420261Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420537Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421084Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421763Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421978Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770422449Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423262Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423477Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26