FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD1553000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD155300
Catalog number
SD155300
Device description
4 1/2" Jaeger Lid Plate, Non-Conductive
Published
2026-07-31
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
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD1553000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386) 738-1202info@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
B382SD309390Surgical DirectSD30939SD309392026-10-20
B382SD4810110Surgical DirectSD48-1011SD48-10112026-10-20
B382SD62362020Surgical DirectSD62362-02SD62362-022026-10-20
B382SD907310070Surgical DirectSD90731007SD907310072026-10-20
B382SD915070010Surgical DirectSD91507001SD915070012026-10-20
B382SD915070020Surgical DirectSD91507002SD915070022026-10-20
B382SD915070030Surgical DirectSD91507003SD915070032026-10-20
B382SD915758300Surgical DirectSD91575830SD915758302026-10-20
B382SD917665100Surgical DirectSD91766510SD917665102026-10-20
B382SD917665110Surgical DirectSD91766511SD917665112026-10-20
B382SD917665120Surgical DirectSD91766512SD917665122026-10-20
B382SD917665700Surgical DirectSD91766570SD917665702026-10-20
B382SD917665920Surgical DirectSD91766592SD917665922026-10-20
B382SD917665930Surgical DirectSD91766593SD917665932026-10-20
B382SD9210921080Surgical DirectSD921092108SD9210921082026-10-20
B382SD922624103T0Surgical DirectSD922624103TSD922624103T2026-10-20
B382SD9228132200Surgical DirectSD922813220SD9228132202026-10-20
B382SD9228132210Surgical DirectSD922813221SD9228132212026-10-20
B382SD9228132220Surgical DirectSD922813222SD9228132222026-10-20
B382SD9228132300Surgical DirectSD922813230SD9228132302026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995317607V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00724995317638V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00724995317645V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00724995317652V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00190776436520MilleniumAvalign Technologies, Inc.HNI2026-10-08
00724995318178V. MuellerSTERIS Deutschland GmbHHNI2026-09-25
00190776403799MillenniumAvalign Technologies, Inc.HNI2026-07-21
00190776403805MillenniumAvalign Technologies, Inc.HNI2026-07-21
00190776420765MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420840MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420512MillenniumAvalign Technologies, Inc.HNI2026-04-16
G22351091I0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2026-04-09
00190776418007MillenniumAvalign Technologies, Inc.HNI2026-03-23
00757770668427Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770708260Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770652518Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
00757770668083Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
G2231109830Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2025-08-11
00757770421985Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770423934Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770455720Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770510405Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770437429Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00757770668519Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00194613005924MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613005948MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613085896MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613104177MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
04058935011826Berke-Jaeger Lid PlateBausch & Lomb GmbHHNI2025-07-11
00850003089355N/AOptalmed, LLCHNI2025-07-07