FDA.reportPublic FDA data

ORLocate

Primary DI
50724995220124
Brand
ORLocate
Company
Steris Corporation
Model
ORLocate Lap Sponge
Catalog number
LTS1818X45
Device description
ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGauze/sponge, internal, x-ray detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995220124PackageGS140In Commercial Distribution
15060356150073PreviousGS10
10724995220126PrimaryGS10
00724995220129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522012450724995220124
1506035615007315060356150073
1072499522012610724995220126
00724995220129007249952201297249952201290724995220129

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency identification readerAn electronic device designed to read information stored on radio-frequency identification (RFID) tags within its read range, typically to identify and track medical devices. The reader may be of the passive (receives data only) or active (transmits and receives data) type, and may have the capability of storing and/or transmitting the read data.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
177360039
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995220228NAArm SupportBF4312024-01-31
00724995225148NABF00066BF000662025-03-31
00724995217280NAPowerLift PlusBF8672022-12-20
00724995225155NABF686BF6862024-04-08
10885403097836V. MuellerOP2610OP26102018-09-07
10885403099878V. MuellerOP6581OP65812019-01-02
10885403099939V. MuellerOP6975OP69752018-09-07
10885403099960V. MuellerOP6990OP69902018-09-07
10885403105395V. MuellerOS5500OS55002018-09-10
10885403111792V. MuellerRH751RH7512018-09-14
10885403112102V. MuellerRH1045RH10452018-09-10
10885403072833V. MuellerNL2750NL27502018-08-30
10885403073090V. MuellerNL3106NL31062018-08-30
10885403073113V. MuellerNL3108NL31082018-08-30
10885403113628V. MuellerRH1830RH18302018-09-10
10885403113635V. MuellerRH1860RH18602018-09-10
10885403014635V. MuellerBE400BE4002018-08-02
10885403026348V. MuellerCH2605CH26052018-08-09
00724995225117NALeg PositionerBF3512023-10-03
10885403008566V. MuellerAU5685AU56852022-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20193489079804MEDLINEMEDLINE INDUSTRIES, INC.GDY2026-10-09
30193489079726MEDLINEMEDLINE INDUSTRIES, INC.GDY2026-10-09
30193489079771MEDLINEMEDLINE INDUSTRIES, INC.GDY2026-10-09
30193489079788MEDLINEMEDLINE INDUSTRIES, INC.GDY2026-10-09
30193489079795MEDLINEMEDLINE INDUSTRIES, INC.GDY2026-10-09
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
20192253046141VistecCardinal Health 200, LLCGDY2025-11-06
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
20192253047223VistecCardinal Health 200, LLCGDY2025-02-07
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29