FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143903539
Brand
SURGIPROS
Company
Surgipros, LLC
Model
385-356SP
Device description
ELEVATOR HOUSE STRUT PICK 0.75MM, 90 DEGREES, 6 1/2"
Published
2023-12-08
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
JYTPick, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143903539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143903539008101439035398101439035390810143903539

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4109600452info@surgipros.com

Regulatory Flags#

DUNS number
058689193
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810143905779SURGIPROSWR412S2026-05-23
00810143907032SURGIPROSBC171SP2026-05-23
00810143907483SURGIPROSBC173SP2026-05-23
00810143907490SURGIPROS5005-44SP2026-05-23
00810143907537SURGIPROSBF113SP2026-05-23
00810212930374SURGIPROSBC181SP2026-05-23
00810212930480SURGIPROSBT041T2026-05-22
00810212930497SURGIPROSFB882SP2026-05-22
00810212930510SURGIPROS50-4681SP2026-05-22
00810212930534SURGIPROS50-4680SP2026-05-22
00810212930664SURGIPROSBC915SP2026-05-23
00810212930671SURGIPROSBC919SP2026-05-23
00810212930725SURGIPROSBC924SP2026-05-23
00810212931340SURGIPROSFB402T2026-05-22
00810212933054SURGIPROSEA016T2026-05-22
00810143905052SURGIPROS7803-65SP2024-09-18
00810143905113SURGIPROS9009-13SP2024-09-18
00810143905120SURGIPROS9009-14SP2024-09-18
00810143905137SURGIPROS3092SP2024-09-18
00810143905144SURGIPROS3099SP2024-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811150288INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
09348811150356INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
00757770682539Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
00757770714049Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
09348811112040INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-12-02
00757770688531Bausch + LombBausch & Lomb IncorporatedJYT2025-11-14
00757770406821Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
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00757770435425Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
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00757770436651Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
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